Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics
A Multi-center, Prospective, Observational Study of Analysis of Q Cell Markers in Patients With Newly Diagnosed Primary Glioblastoma (Phase IV)
1 other identifier
observational
240
1 country
1
Brief Summary
The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 28, 2014
January 1, 2014
2.8 years
January 21, 2014
January 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The effect of each single molecular marker of Q cell on progression-free survival
Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of first surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of first surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model.
3-5 days postoperatively
The effect of each single molecular marker of Q cell on overall survival
Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of first surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of first surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model.
3-5 days postoperatively
Secondary Outcomes (1)
We will correlate molecular markers of Q cell with other genetic alterations
3-5 days postoperatively
Study Arms (1)
high-risk
high-risk is determined by the evaluation of the biomarkers of Q cell.
Eligibility Criteria
Patients with glioblastoma undergo operation and sufficient tumor specimens
You may qualify if:
- \>=18 years old
- Primary Glioblastoma is newly diagnosed and confirmed histologically
- Patient is expected to be treated with temozolomide and followed up routinely at the study site.
- Willing to sign the informed consent
You may not qualify if:
- Currently enrolled in any other clinical study
- History of any other malignancies
- Refusal to give consent
- No available tumor tissue for IDH analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangzhou General Hospital of Guangzhou Military Commandcollaborator
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical Universitycollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Capital Medical Universitycollaborator
- Tianjin Medical University General Hospitalcollaborator
- Shenzhen Second People's Hospitalcollaborator
- Huashan Hospitalcollaborator
- West China Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- First Hospital of China Medical Universitycollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Second Affiliated Hospital of Soochow Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Guangzhou First People's Hospitalcollaborator
- Xi'an Jiaotong Universitycollaborator
- Southern Medical University, Chinacollaborator
- Second Affiliated Hospital of Guangzhou Medical Universitycollaborator
Study Sites (1)
Nanfang Glioma Centre
Guangzhou, Guangdong, 510515, China
Related Publications (3)
SongTao Q, Lei Y, Si G, YanQing D, HuiXia H, XueLin Z, LanXiao W, Fei Y. IDH mutations predict longer survival and response to temozolomide in secondary glioblastoma. Cancer Sci. 2012 Feb;103(2):269-73. doi: 10.1111/j.1349-7006.2011.02134.x. Epub 2011 Nov 28.
PMID: 22034964BACKGROUNDQi ST, Yu L, Lu YT, Ou YH, Li ZY, Wu LX, Yao F. IDH mutations occur frequently in Chinese glioma patients and predict longer survival but not response to concomitant chemoradiotherapy in anaplastic gliomas. Oncol Rep. 2011 Dec;26(6):1479-85. doi: 10.3892/or.2011.1428. Epub 2011 Aug 19.
PMID: 21874255BACKGROUNDSturm D, Witt H, Hovestadt V, Khuong-Quang DA, Jones DT, Konermann C, Pfaff E, Tonjes M, Sill M, Bender S, Kool M, Zapatka M, Becker N, Zucknick M, Hielscher T, Liu XY, Fontebasso AM, Ryzhova M, Albrecht S, Jacob K, Wolter M, Ebinger M, Schuhmann MU, van Meter T, Fruhwald MC, Hauch H, Pekrun A, Radlwimmer B, Niehues T, von Komorowski G, Durken M, Kulozik AE, Madden J, Donson A, Foreman NK, Drissi R, Fouladi M, Scheurlen W, von Deimling A, Monoranu C, Roggendorf W, Herold-Mende C, Unterberg A, Kramm CM, Felsberg J, Hartmann C, Wiestler B, Wick W, Milde T, Witt O, Lindroth AM, Schwartzentruber J, Faury D, Fleming A, Zakrzewska M, Liberski PP, Zakrzewski K, Hauser P, Garami M, Klekner A, Bognar L, Morrissy S, Cavalli F, Taylor MD, van Sluis P, Koster J, Versteeg R, Volckmann R, Mikkelsen T, Aldape K, Reifenberger G, Collins VP, Majewski J, Korshunov A, Lichter P, Plass C, Jabado N, Pfister SM. Hotspot mutations in H3F3A and IDH1 define distinct epigenetic and biological subgroups of glioblastoma. Cancer Cell. 2012 Oct 16;22(4):425-37. doi: 10.1016/j.ccr.2012.08.024.
PMID: 23079654BACKGROUND
Biospecimen
tumor sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Songtao Qi, Doctor
Nanfang Glioma centre, Guangzhou, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 28, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
January 28, 2014
Record last verified: 2014-01